@38Lemma Жыл бұрын
Thank you for this video, very well explained
@MedicalDeviceAcademy Жыл бұрын
Glad it was helpful! It was an idea that resulted from a client that didn't know what "510(k) exempt" meant. The best topics are always from customer and potential customers. Rob
@ABDU7194 5 ай бұрын
Nice and clear
@MedicalDeviceAcademy 5 ай бұрын
Glad you think so!
@user-lm6nx3he4p Жыл бұрын
great video! thank you. Sorry, where can i find the "next video" about regulatory pathway analysis mentioned?
@MedicalDeviceAcademy Жыл бұрын
This video was recorded on March 3, 2023. The next video was on March 10, 2023: kzfaq.infoLc3NIeav-bM. You can search our channel for video topics as well.
@mosheyt1 4 ай бұрын
for class 1 exempt but not GMP exempt, do I need to be in compliance with full 820 or procedures just per the associated risk of the device?
@MedicalDeviceAcademy 4 ай бұрын
Class 1 device are exempt from design controls (i.e., 21 CFR 820.30), unless the device is one of the 5 device types listed in 21 CFR 820.30(a)(2)(ii) listed below or automated with computer software: 1.Catheter, Tracheobronchial Suction 2. Glove, Surgeon's 3. Restraint, Protective 4. System, Applicator, Radionuclide, Manual 5. Source, Radionuclide Teletherapy You also indicated that the device is not GMP exempt. Therefore, all other sections of 21 CFR 820 will apply. There are some typical exceptions (e.g., installation and service do not apply to all devices).
@sanas8244 Жыл бұрын
Awesome presentation!!
@MedicalDeviceAcademy Жыл бұрын
Glad you liked it!
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